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多囊卵巢综合征患者行体外受精治疗中,采用灵活 GnRH 拮抗剂方案与 GnRH 激动剂长方案的前瞻性随机对照试验(RCT)。

Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT).

机构信息

Eugonia-Iatriki Erevna IVF Center, Athens, Greece.

出版信息

Hum Reprod. 2010 Mar;25(3):683-9. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15.

Abstract

BACKGROUND

Women with polycystic ovary syndrome (PCOS) are at risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation. Use of GnRH antagonist in the general subfertile population is associated with lower incidence of OHSS than agonists and similar probability of live birth but it is unclear if this is true for patients with PCOS. Our aim was to compare the flexible GnRH antagonist and GnRH agonist long protocols in patients with PCOS undergoing IVF (primary end-point: ongoing pregnancy rate per patient randomized).

METHODS

In this randomised controlled trial (RCT), 220 patients with PCOS were randomly allocated in two groups: long GnRH agonist down-regulation protocol (n = 110) and flexible GnRH antagonist protocol (n = 110).

RESULTS

No differences were observed in ongoing pregnancy rates [50.9 versus 47.3%, difference 3.6%, 95% confidence interval (CI): -9.6 to +16.8%] in the agonist and antagonist protocols, respectively. Incidence of OHSS Grade II was lower in the antagonist compared with agonist group (40.0 versus 60.0%, difference -20.0%, 95% CI: -7.1 to -32.9%, P < 0.01). Duration of stimulation (10 versus 12 days, difference 2 days, 95% CI: +1 to +2, P < 0.001) and total gonadotrophin required (1575 versus 1850 IU, difference -275 IU, 95% CI: -25 to -400, P < 0.05) were also lower in the antagonist compared with agonist protocol.

CONCLUSIONS

The current RCT suggests that the flexible GnRH antagonist protocol is associated with a similar ongoing pregnancy rate, lower incidence of OHSS grade II, lower gonadotrophin requirement and shorter duration of stimulation, compared with GnRH agonist. The GnRH antagonist might be the treatment choice for patients with PCOS undergoing IVF. The study was registered at clinicaltrials.gov. ID: NCT00417144.

摘要

背景

多囊卵巢综合征(PCOS)女性在卵巢刺激过程中发生卵巢过度刺激综合征(OHSS)的风险增加。在普通不孕人群中使用 GnRH 拮抗剂与 GnRH 激动剂相比,OHSS 的发生率较低,活产率相似,但对于 PCOS 患者是否如此尚不清楚。我们的目的是比较接受 IVF 的 PCOS 患者中灵活 GnRH 拮抗剂和 GnRH 激动剂长方案,主要终点为每个随机分组患者的持续妊娠率。

方法

在这项随机对照试验(RCT)中,220 名 PCOS 患者被随机分为两组:长 GnRH 激动剂下调方案(n = 110)和灵活 GnRH 拮抗剂方案(n = 110)。

结果

在激动剂和拮抗剂方案中,持续妊娠率分别为 50.9%和 47.3%[差异 3.6%,95%置信区间(CI):-9.6%至+16.8%],未见差异。拮抗剂组 OHSS Ⅱ级的发生率低于激动剂组(40.0%比 60.0%,差异-20.0%,95%CI:-7.1%至-32.9%,P < 0.01)。拮抗剂组的刺激持续时间(10 天比 12 天,差异 2 天,95%CI:+1 至+2,P < 0.001)和所需总促性腺激素(1575IU 比 1850IU,差异-275IU,95%CI:-25 至-400,P < 0.05)也低于激动剂组。

结论

当前的 RCT 表明,与 GnRH 激动剂相比,灵活 GnRH 拮抗剂方案具有相似的持续妊娠率、较低的 OHSS Ⅱ级发生率、较低的促性腺激素需求和较短的刺激持续时间,对于接受 IVF 的 PCOS 患者可能是一种治疗选择。该研究在 clinicaltrials.gov 注册,ID:NCT00417144。

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